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Job Title: Regulatory Affairs Specialist - US FDA Class III Medical Devices
Location: Hybrid (Onsite 2-3 days per week) - Must reside in the Raleigh-Durham area
Schedule: Monday-Friday, full-time

Position Summary:
The Regulatory Affairs Specialist will support regulatory activities for existing US FDA Class III medical devices and combination products. This role provides guidance on product and process changes, ensures regulatory compliance, prepares submissions, and collaborates with cross-functional teams. The ideal candidate is analytical, curious, and a self-starter who communicates effectively and thrives in a collaborative environment.

Key Responsibilities:

1. Regulatory Strategy

   • Support regulatory strategy development for post-market lifecycle of US FDA Class III devices and combination products.

2. Regulatory Assessments

   • Review product and process changes and conduct regulatory assessments.

   • Conduct risk assessments and recommend strategies to mitigate regulatory risks.

3. Regulatory Submissions

   • Prepare, review, and submit regulatory filings, including PMA supplements and post-market reports.

4. Regulatory Compliance

   • Maintain regulatory documentation and databases in accordance with internal procedures and applicable regulations (e.g., FDA, ISO, USP).

5. Regulatory Interface & Communication

   • Respond to inquiries from regulatory agencies and coordinate responses with subject matter experts.

   • Keep internal stakeholders informed during submission approvals and regulatory interactions.

6. Cross-Functional Collaboration

   • Partner with Quality, Operations, Marketing, and Supply Chain teams to ensure compliance throughout the product lifecycle.

7. Document Management

   • Maintain regulatory documentation in accordance with company policies and departmental standards.

Technical & Functional Skills:

• Knowledge of medical device regulations (21 CFR 814, 21 CFR 820) and Quality Management Systems (ISO 13485, ISO 9001).

• Strong analytical, investigative, and organizational skills.

• Ability to prioritize and manage multiple tasks under pressure.

• Self-starter with results-oriented mindset.

• Excellent written and verbal communication skills.

Minimum Qualifications:

• University degree in scientific discipline preferred (or equivalent experience).

• 4+ years' experience in the medical device industry.

• 2+ years' direct experience in regulatory affairs for FDA Class II or III devices.

• Knowledge of Quality Management System standards (ISO 13485, ISO 9001).

• Proficiency in Microsoft Office (Excel, PowerPoint, Word).

Preferred Qualifications:

• Prior experience with Class II or III medical devices.

• Strong communication skills.

• Ability to adapt quickly in a fast-paced environment.

Physical Requirements:

• Ability to sit, stand, and perform general office functions.

• Occasional lifting of up to 25 pounds.

• Frequent bending, stooping, and reaching.

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